PlainRecalls
FDA Devices Moderate Class II Terminated

T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Reported: June 20, 2012 Initiated: June 1, 2012 #Z-1809-2012

Product Description

T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Reason for Recall

The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.

Details

Units Affected
23,653 ( past 3 years) 47937 all years
Distribution
Worldwide Distribution - US (nationwide) including the states of: AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the country of SWITZERLAND
Location
Portage, MI

Frequently Asked Questions

What product was recalled? ▼
T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 23,653 ( past 3 years) 47937 all years.
Why was this product recalled? ▼
The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 20, 2012. Severity: Moderate. Recall number: Z-1809-2012.

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